FDA Issues Restrictions on Prescription Codeine and Tramadol Medications for Children

FDA Issues Restrictions on Prescription Codeine and Tramadol Medications for Children

The Food and Drug Administration (FDA) recently reported that it is requiring makers of codeine and tramadol products to change their labels to warn against giving them to children under the age of 12, and to limit use in certain older children. The FDA is also recommending against the use of these medications in breastfeeding mothers due to possible harm to their infants.

Codeine (FDA-approved to treat pain and cough in adults) and tramadol (approved to treat pain), carry serious health risks for children younger than 12 years, including slowed or difficult breathing and death, and, therefore, should not be used in these children.

A top official at the FDA’s Center for Drug Evaluation and Research, Douglas Throckmorton, said that some children are “ultrarapid metabolizers” who process the drugs faster than others, leading to dangerously high levels of the drug.

Healthcare professionals are being asked to consider recommending over-the-counter or other FDA-approved prescription medications for cough and pain management in children younger than 12 years and in adolescents younger than 18 years, especially those with certain genetic factors, obesity, or obstructive sleep apnea and other breathing problems.